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The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.
The primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among pregnant women with posterior pelvic girdle pain. The investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved NPRS scores compared to receipt of an educational pamphlet alone.
This study will include English-speaking pregnant women presenting to Loyola University Medical Center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an NPRS score > 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of 10 (Worst possible pain).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryotherapy + education | Experimental | intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture |
|
| education alone | Active Comparator | The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Other | intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pelvic girdle pain using the Numeric Pain Rating Scale | The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain). | On day 6 |
| Change in pelvic girdle pain using the Pelvic Girdle Questionnaire | The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent). | On day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Fitzgwerald, MD | Loyola Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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| ID | Term |
|---|---|
| D059388 | Pelvic Girdle Pain |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Study participants will then be randomized to cryotherapy + education vs. education alone. The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture.
Those randomized to the intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) at this initial visit where they will be monitored for any adverse response as well as for any immediate change to the NPRS and PGQ. The participant will place the icepack over the low back region and the sacrum if the pain is bilateral. If the pain is unilateral will place the icepack over just that side.
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| Education | Other | The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |